Zephyrnet Logo

Tag: Health Sciences Authority

HSA Revised Guidance on Medical Device Product Registration: Specific Aspects | HSA

The new article highlights specific points related to medical device registration in Singapore under the existing legal framework. Table of content ...

Top News

HSA Guidance on Site Master File Preparation: Overview

The document describes in detail the aspects to be taken into account when preparing a site master file....

HSA Guidance on “Dear Healthcare Professional” Letters: Overview

The article provides an overview of the regulatory requirements related to the content of special communications to be...

HSA Guidance on Complaints Handling: Overview

The document highlights the key points related to the regulatory requirements for handling complaints associated with medical devices...

HSA Guidance on Recalls: Overview

The article provides an overview of the regulatory requirements for medical device recalls. ...

HSA Guidance on FSCA: Specific Aspects

The new article highlights the aspects related to field safety corrective actions including, inter alia, the record-keeping requirements,...

HSA Guidance on Field Safety Corrective Actions: Risk Management Process

The new article highlights the aspects related to the risk management process for the supply of medical devices. ...

HSA Guidance on FSCA: Specific Device Types

The new article highlights the aspects related to the specific associated with certain types of medical devices, including...

HSA Guidance on FSCA: Content of Reports

The new article highlights the aspects related to the content of reports to be submitted by the parties...

HSA Guidance on FSCA: Initiating the Actions

The new article highlights the aspects related to the commencement of corrective actions and the appropriate notification requirements....

HSA Guidance on Reclassification: Medical Devices to be Introduced Into the Body

The article provides an overview of the changes to the applicable classification rules with respect to a specific...

HSA Guidance on Adverse Events Reporting: IVDs and Timelines

The new article highlights the key points related to reporting adverse events associated with in vitro diagnostic medical...

HSA Guidance on the Reporting of Adverse Events: Overview

The article provides an overview of the regulatory requirements in the sphere of adverse event reporting.  ...

Latest Intelligence

spot_img
spot_img

Chat with us

Hi there! How can I help you?